Label: MEASTEM FIRST AID AND ANTIBIOTIC- tetracycline hydrochloride spray

  • NDC Code(s): 79218-002-01, 79218-002-02
  • Packager: MATRIX MIXOLOGY, INC
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 5, 2021

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  • Drug Facts

  • Active Ingredient (in each gram)

    Tetracycline-HCL 30mg

    Purpose

    First Aid/Antibiotic

  • Indications

    First aid to help prevent the risk of skin infection in minor cuts, scrapes, or burns.

  • Warnings

    For external use only. May be harmful if swallowed.

    AllergyAlert

    Do not use if allergic to any ingredient listed on this label.

    Do not use

    ■ in eyes

    ■ over large areas of the body 

    ■ longer than 1 week unless directed by doctor

    Ask a doctor before use if you have

    ■ deep or puncture wounds

    ■ animal bites 

    ■ serious trauma

    Stop use and ask a doctor

    if condition persists or gets worse.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison control Center right away.

  • Directions

    ■ clean the affected area
    ■ apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
    ■ may be covered with a sterile bandage

    Stop use if product is misused

    ■ this product is an OTC antibiotic for human use
    ■ contains no alcohol, no animal ingredients
    ■ blended for typical skin color
    ■ may stain cloth
    ■ no claims regarding stem cell healing are implied for this product

  • Other Information

    ■ For best results refrigerate or store in a cool dark place.

  • Inactive Ingredients

    acetic acid, ascorbic acid, chlorhexidine gluconate, cholecalciferol, dimethyl sulfoxide, dipropylene glycol, glucono delta lactone, glycerin, histidine, hydroxethyl-cellulose, magnesium stearate, sodium hydroxide, sorbic acid, stearic acid, water

  • Package Labeling:15ml

    LabelBox

  • Package Labeling:55ml

    Label2Box2

  • INGREDIENTS AND APPEARANCE
    MEASTEM FIRST AID AND ANTIBIOTIC 
    tetracycline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79218-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TETRACYCLINE HYDROCHLORIDE (UNII: P6R62377KV) (TETRACYCLINE - UNII:F8VB5M810T) TETRACYCLINE HYDROCHLORIDE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HISTIDINE (UNII: 4QD397987E)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBIC ACID (UNII: X045WJ989B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79218-002-011 in 1 BOX12/31/2020
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:79218-002-021 in 1 BOX12/31/2020
    255 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B12/31/2020
    Labeler - MATRIX MIXOLOGY, INC (128885636)